Aventis/Vertex halt RA trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Aventis and Vertex voluntarily discontinue Phase IIb trial of their rheumatoid arthritis therapy pralnacasan based on results from a nine-month animal toxicology study showing liver abnormalities. No liver toxicity has been seen in clinical trials of the oral interleukin-1 beta converting enzyme inhibitor, the companies maintain. The decision to halt the RA study follows requested discussions with FDA. Two shorter-term, ongoing Phase I studies will continue. Vertex stock dropped over 30% after the Nov. 10 announcemen